DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7, 9, 11-12, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US 20190298987) in view of Leonard II (US 20220314014).
Regarding claim 1, Freeman discloses a garment 110 configured to generate an AC voltage (section 0148, 0171, The device then causes one or more therapeutic shocks, for example, defibrillating and/or pacing shocks, to be delivered to the body of the patient. each defibrillation pulse can deliver between 60 to 400 joules (J) of energy. In some implementations, the defibrillating pulse can be a biphasic truncated exponential waveform, whereby the signal can switch between a positive and a negative portion), the garment 110 comprising: a support layer configured to be worn on a subject's body (Section 0161, at least some of the components of the medical device can be configured to be affixed to the garment or in some examples, permanently secured into the garment, which can be worn about the patient's torso); an amplifier 202 for converting an input voltage to the AC voltage (Section 0183-0184, the therapy delivery circuit can include one or more power converters for controlling the charging and discharging of the one or more capacitors); control circuitry 218 communicatively coupled to the amplifier and configured to control the frequency and amplitude of the AC voltage output from the amplifier (section 0183, voltage and/or current measuring components, and other similar circuitry components arranged and connected such that the circuitry components work in concert with the therapy delivery circuit 202 and under control of one or more processors (e.g., processor 218) to provide, for example, one or more pacing or defibrillation therapeutic pulses); and at least one battery 210 coupled to the amplifier and configured to supply the input voltage to the amplifier (section 0206, the garment 110 removably couples to a rechargeable battery 210 for powering the plurality of capacitors); wherein the amplifier 202 , the control circuitry 218, and the at least one battery 210 are integrated into the garment such that the weight of the amplifier, the control circuitry, and the at least one battery is supported by the support layer (Fig. 4A-B, Sections 0205, 0207, 0214, the garment 110 may be washed or worn in shower without damaging the electrical components that are permanently disposed into the garment 110. In implementations at least one of the plurality of sensing electrodes 112, the plurality of therapy electrodes 114, and one or more components of the controller 120 e.g. capacitors 403, therapy delivery circuit 202, processor 218 are housed in one or more water resistant housings, or enclosures).
However, Freeman does not disclose the frequency of the AC voltage output from the amplifier is in a range of 50kHz to 1MHz. Leornard II discloses a garment (abstract, section 0034, the coupling apparatus can comprise a belt , a strap , and/or a sleeve) for generating AC voltage with the frequency of the AC voltage output from the amplifier is in a range of 50kHz to 1MHz (section 0030, the frequency of the alternating voltage can be between 50 kHz and 1 MHz, or between 100 kHz and 500 kHz). This allows for proper AC electric fields at specific frequencies to be delivered for treating tissues of a subject’s body. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Freeman by adding generating AC voltage with the frequency of the AC voltage output from the amplifier is in a range of 50kHz to 1MHz as taught by Leonard II in order to facilitate proper AC electric fields at specific frequencies to be delivered for treating tissues of a subject’s body.
Regarding claim 2, Freeman in view of Leonard II, specfically, Freeman discloses the garment comprises a vest (section 0014, 0034, the garment includes at least one of a vest worn about the torso of the patient).
Regarding claim 3, Freeman discloses one or more of the at least one battery 210 is disposed at a location of the support layer under an arm hole of the vest (Fig. 1-2, section 0187, the garment may include a vest portion worn about an upper torso of the patient and a separate belt portion that is detachable from the vest. In this example, the sensing electrodes and/or therapy electrodes may be a permanent portion of the vest and the various modules (e.g., the therapy delivery circuit , the sensor interface , the processor , the network interface , and the user interface , battery, described with regard to FIG. 2) may be removably or permanently attached to the belt portion).
Regarding claim 4, Freeman in view of Leonard II, specfically, Freeman discloses the garment comprises a belt or fanny pack (section 0187, the garment may include a vest portion worn about an upper torso of the patient and a separate belt portion that is detachable from the vest).
Regarding claim 5, Freeman in view of Leonard II, specfically Freeman discloses the support layer comprises at least one compartment holding one or more of the at least one battery, the amplifier, and/or the control circuitry therein (Figs. 1-2, section 0187, the sensing electrodes and/or therapy electrodes may be a permanent portion of the vest and the various modules (e.g., the therapy delivery circuit , the sensor interface , the processor , the network interface , and the user interface , battery, described with regard to FIG. 2) may be removably or permanently attached to the belt portion).
Regarding claim 6, Freeman in view of Leonard II, specfically Freeman discloses one or more of the at least one battery is removably disposed in the support layer and is replaceable with at least one other battery (Figs. 1-2, section 0187, the sensing electrodes and/or therapy electrodes may be a permanent portion of the vest and the various modules (e.g., the therapy delivery circuit , the sensor interface , the processor , the network interface , and the user interface , battery, described with regard to FIG. 2) may be removably or permanently attached to the belt portion).
Regarding claim 7, Freeman in view of Leonard II, specfically Freeman discloses the control circuitry is coupled to the at least one battery and configured to monitor a remaining charge of the at least one battery (section 0183, voltage and/or current measuring components, and other similar circuitry components arranged and connected such that the circuitry components work in concert with the therapy delivery circuit 202 and under control of one or more processors (e.g., processor 218) to provide, for example, one or more pacing or defibrillation therapeutic pulses).
Regarding claim 9, Freeman in view of Leonard II, specfically Freeman discloses at least a skin-facing portion of the support layer is washable (Section 0214, the garment 110 may be washed).
Regarding claim 11, Freeman in view of Leonard II, specfically Freeman discloses a lead connector electrically coupled to the amplifier and configured to transmit the AC voltage to leads for a pair of transducers and to receive sensor signals from the pair of transducers, the lead connector being integrated into the garment such that the weight of the lead connector is supported by the support layer (section 0190, the therapy electrodes 114 and the sensing electrodes 112 are electrically connected to the controller 120 and the therapy delivery circuit 202 by one or more wires 121a, 121b. The one or more wires 121a, 121b may be woven into the garment ).
Regarding claim 12, Freeman in view of Leonard II, specfically Freeman discloses leads for coupling the amplifier to a pair of transducers, the leads being located within the support layer such that the leads do not contact the subject's skin while the subject is wearing the garment (section 0190, the therapy electrodes 114 and the sensing electrodes 112 are electrically connected to the controller 120 and the therapy delivery circuit 202 by one or more wires 121a, 121b. The one or more wires 121a, 121b may be woven into the garment).
Regarding claim 16, Freeman in view of Leonard II, specfically Freeman discloses a reflective material or an insulating material located between the amplifier and a skin-facing portion of the support layer (section 0191, In some implementations, the one or more wires 121a, 121b can be insulated in a cable routed discreetly in a hemline of the garment ).
Regarding claim 17, Freeman in view of Leonard II, specfically Freeman discloses a cooling system configured to cool the amplifier 202, the cooling system being integrated into the garment such that the weight of the cooling system is supported by the support layer (Fig. 4B shows the sleeveless shirt and the amplifier attached to the body and open to air for cooling purposes).
Regarding claim 18, Freeman discloses a system configured to generate an AC voltage (section 0148, 0171, The device then causes one or more therapeutic shocks, for example, defibrillating and/or pacing shocks, to be delivered to the body of the patient. each defibrillation pulse can deliver between 60 to 400 joules (J) of energy. In some implementations, the defibrillating pulse can be a biphasic truncated exponential waveform, whereby the signal can switch between a positive and a negative portion), comprising: a first garment 110 comprising a vest configured to be worn on a subject's body (section 0014, 0034, the garment includes at least one of a vest worn about the torso of the patient); a second garment comprising a belt or fanny pack configured to be worn on the subject's body (section 0187, the garment may include a vest portion worn about an upper torso of the patient and a separate belt portion that is detachable from the vest); an amplifier 202 for converting an input voltage to the AC voltage (Section 0183-0184, the therapy delivery circuit can include one or more power converters for controlling the charging and discharging of the one or more capacitors); control circuitry 218 communicatively coupled to the amplifier and configured to control the frequency and amplitude of the AC voltage output from the amplifier (section 0183, voltage and/or current measuring components, and other similar circuitry components arranged and connected such that the circuitry components work in concert with the therapy delivery circuit 202 and under control of one or more processors (e.g., processor 218) to provide, for example, one or more pacing or defibrillation therapeutic pulses); and at least one battery 210 coupled to the amplifier and configured to supply the input voltage to the amplifier (section 0206, the garment 110 removably couples to a rechargeable battery 210 for powering the plurality of capacitors); wherein the amplifier 202 , the control circuitry 218, and the at least one battery 210 are integrated into the first and second garments such that the weight of the amplifier, the control circuitry, and the at least one battery is supported by the combination of the vest and the belt or fanny pack (Fig. 4A-B, Sections0187, 0205, 0207, 0214, Figs. 1-2, section 0187, the sensing electrodes and/or therapy electrodes may be a permanent portion of the vest and the various modules (e.g., the therapy delivery circuit , the sensor interface , the processor , the network interface , and the user interface, battery, described with regard to FIG. 2) may be removably or permanently attached to the belt portion. The garment 110 may be washed or worn in shower without damaging the electrical components that are permanently disposed into the garment 110. In implementations at least one of the plurality of sensing electrodes 112, the plurality of therapy electrodes 114, and one or more components of the controller 120 e.g. capacitors 403, therapy delivery circuit 202, processor 218 are housed in one or more water resistant housings, or enclosures).
However, Freeman does not disclose the frequency of the AC voltage output from the amplifier is in a range of 50kHz to 1MHz. Leornard II discloses a garment (abstract, section 0034, the coupling apparatus can comprise a belt , a strap , and/or a sleeve) for generating AC voltage with the frequency of the AC voltage output from the amplifier is in a range of 50kHz to 1MHz (section 0030, the frequency of the alternating voltage can be between 50 kHz and 1 MHz, or between 100 kHz and 500 kHz). This allows for proper AC electric fields at specific frequencies to be delivered for treating tissues of a subject’s body. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Freeman by adding generating AC voltage with the frequency of the AC voltage output from the amplifier is in a range of 50kHz to 1MHz as taught by Leonard II in order to facilitate proper AC electric fields at specific frequencies to be delivered for treating tissues of a subject’s body.
Regarding claim 19, Freeman in view of Leonard II, specfically Freeman discloses the amplifier 202 is disposed in the vest, at least a portion of the control circuitry is disposed in the vest, and one or more of the at least one battery 210 is disposed in the belt or fanny pack (Figs. 1-2, section 0187, the sensing electrodes and/or therapy electrodes may be a permanent portion of the vest and the various modules (e.g., the therapy delivery circuit , the sensor interface , the processor , the network interface , and the user interface, battery, described with regard to FIG. 2) may be removably or permanently attached to the belt portion)
Regarding claim 20, Freeman in view of Leonard II, specfically Freeman discloses the amplifier is disposed in the belt or fanny pack, at least a portion of the control circuitry is disposed in the vest, and one or more of the at least one battery is disposed in the vest (Figs. 1-2, section 0187, the sensing electrodes and/or therapy electrodes may be a permanent portion of the vest and the various modules (e.g., the therapy delivery circuit , the sensor interface , the processor , the network interface , and the user interface, battery, described with regard to FIG. 2) may be removably or permanently attached to the belt portion).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US 20190298987) in view of Leonard II (US 20220314014) in view of McIntyre (US 20220030987).
Regarding claim 13, Freeman in view of Leonard II discloses the invention substantially as claimed however does not specfically discloses a charge port coupled to the amplifier, the charge port being integrated into the garment such that the weight of the charge port is supported by the support layer.
McIntyre discloses a garment 10 with a charge port 50 coupled to the amplifier, the charge port being integrated into the garment such that the weight of the charge port is supported by the support layer (Fig. 5A-B, 7, section 0063, 0070, the connector plug 258′, 258″ includes the flexible wire/cable 98 extending from the pocket 88, 88″ to connect the battery controller 50′, 50″ (along with the battery pack 22) to the glove circuit portion 256 of the glove 10′, 10″. To connect to the glove circuit portion, 256, the user opens the pocket 88, 88″ to access the plug connector 258 (FIG. 5A), and the receptacle 50′, 50″ (along with the supported battery pack 22) is connected by the connector plug. The illustrated receptacle 50 is operable separate from the glove 10 to, for example, charge the battery pack 22, power another electrical device (not shown), etc.). This allows for the battery of the control circuit to have an easy access to be properly charged. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Freeman in view of Leonard II by adding a charge port as taught by McIntyre in order to facilitate the battery of the control circuit to have an easy access to be properly charged.
Regarding claim 14, Freeman in view of Leonard II discloses the invention substantially as claimed however does not does not specifically discloses the charge port is coupled to the at least one battery and the control circuitry, wherein the control circuitry is configured to selectively direct power from the charge port to the at least one battery for charging the at least one battery or to the amplifier for supplying the input voltage.
McIntyre discloses the charge port is coupled to the at least one battery and the control circuitry, wherein the control circuitry is configured to selectively direct power from the charge port to the at least one battery for charging the at least one battery or to the amplifier for supplying the input voltage (Fig. 5A-B, 7, section 0063, 0070, the connector plug 258′, 258″ includes the flexible wire/cable 98 extending from the pocket 88, 88″ to connect the battery controller 50′, 50″ (along with the battery pack 22) to the glove circuit portion 256 of the glove 10′, 10″. To connect to the glove circuit portion, 256, the user opens the pocket 88, 88″ to access the plug connector 258 (FIG. 5A), and the receptacle 50′, 50″ (along with the supported battery pack 22) is connected by the connector plug. The illustrated receptacle 50 is operable separate from the glove 10 to, for example, charge the battery pack 22, power another electrical device (not shown), etc.). This allows for the battery of the control circuit to have an easy access to be properly charged. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Freeman in view of Leonard II by adding a charge port as taught by McIntyre in order to facilitate the battery of the control circuit to have an easy access to be properly charged.
Allowable Subject Matter
Claim(s) 8, 10, 15 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796